Government Accountability Project 

National Office 

1612 K Street, NW Suite #1100 • Washington, D.C. 20006 

202.408.0034 • www.whistleblower.org

March 20, 2006 

 Via Fax and E-mail to NIOCINDOCKET@cdc.gov

John Howard, MD 

Director 

National Institute for Occupational Safety and Health 

200 Independence Ave, SW 

Washington, DC 20201 

NIOSH Docket Office 

Robert A. Taft Laboratories 

4676 Columbia Parkway 

Cincinnati, OH 45226 

RE: Comments on HHS Interim Final Rule--Procedures for Designating Classes of Employees as 

Members of the Special Exposure Cohort Under the Energy Employees Occupational Illness 

Compensation Program Act of 2000 (RIN 920-AA13)

Dear Dr. Howard: 

 The Government Accountability Project (“GAP”) appreciates the opportunity to 

comment on the Department of Health and Human Services (“HHS”) Interim Final Rule 

“Procedures for Designating Classes of Employees as Members of the Special Exposure Cohort 

Under the Energy Employees Occupational Illness Compensation Program Act of 2000” which 

was published in the Federal Register on December 22, 2005 (70 FR 75949).1

 The Interim Final 

Rule (“IFR”) amends 42 CFR Part 83 (published on May 28, 2004), and purports to incorporate 

the amendments to the Energy Employees Occupational Illness Compensation Program Act 

(“EEOICPA”), which were enacted into law on October 28, 2004 as part of the FY 05 Defense 

Authorization Act (P. L.108-375). 

 With respect to deadlines governing the designation of Special Exposure Cohort (“SEC”) 

petitions, the 2004 amendments state: 

 1

 Amongst its programs activities, GAP oversees the implementation of EEOICPA, and 

worked on the enactment of the Special Exposure Cohort amendments to EEOICPA that were 

included in the FY 05 Defense Authorization Act. GAP also provided oral comment on this 

Interim Final Rule at the ABRWH Meeting on January 24-26, 2006 in Oak Ridge, TN 
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“DEADLINES—(1) Not later than 180 days after the date on which the 

President receives a petition for designation as members of the Special 

Exposure Cohort, the Director of the National Institute for Occupational 

Safety and Health shall submit to the Advisory Board on Radiation and 

Worker Health a recommendation on that petition, including all 

supporting documentation.”

 The Conference Report to the FY 05 Defense Authorization Act (H. Rep.108-767) 

provided additional legally binding guidance regarding what must take place within this 180 day 

time period: 

“To ensure that applications to be a SEC member are processed promptly, 

new timelines have been included. Within 180 days of receipt of a petition 

for designation as members of a SEC, the Director of NIOSH must submit 

to the Advisory Board a recommendation on that petition, including all 

supporting documentation. During the 180 period when NIOSH is 

preparing the petition for review by the Advisory Board, NIOSH should 

identify all deficiencies in the petition within the first 30 days. When the 

President receives an affirmative recommendation from the Advisory 

Board to designate a class to the SEC, the President shall have a period of 

30 days in which to accept or reject the recommendation and notify 

Congress. If the President does not send a determination notice within 30 

days, and if there is an affirmative Board recommendation, the class 

recommended to be a SEC will automatically become a SEC, subject to a 

30 day notification period in Congress.” (emphasis added) 

 GAP provides the following comments, identifies key weaknesses and provides 

suggestions on additions to the rule: 

1. The Interim Final Rule (IFR) in §83.5 and §83.11 never once mentions the 180-day 

deadline for making a recommendation to the Advisory Board on Radiation and Worker 

health (“ABRWH”) upon receipt of the petition. Although the Preamble to the rule states 

that the statutory deadlines are the reason for the rulemaking, there is no reason why the 

180-day deadline is left out. Setting forth the 180-day time limit within the body of the 

rule is not “superfluous” simply because the deadline was included in the law, as was 

suggested by CDC staff. If CDC were consistent in its argument, why is it including the 

30-day statutory deadline for Secretarial action upon receiving an ABRWH 

recommendation? Why is this 30-day deadline included in the IFR, but the 180-day 

requirement is not? One possible explanation for the inconsistency is that CDC has a 

tactical reason to build-in ambiguity on exactly when the 180-day clock begins and ends, 

and wants to have room to hedge on the specific obligations it is prepared to honor. From 

a claimant perspective, this ambiguity appears to be designed to make it harder to hold 

the agency to the requirements of the law. It also will invite Congress, we suspect, to be 
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even more prescriptive in drafting deadlines. We urge HHS to include the 180 day 

deadline for processing petitions in Sections 83.5 and 83.11. 

2. The IFR sets forth no consequences for missing the 180-day deadline. We note that 

NIOSH has already missed the 180-day deadline for issuing recommendations on several 

SEC Petitions that were filed after enactment of P.L. 108-375, including Rocky Flats and 

Oak Ridge Y-12. NIOSH admits that it has not complied with the law. We urge HHS to 

include a provision which requires NIOSH to submit its petition to the Advisory Board, 

or on before the 180th day, and if it fails to meet this deadline to have the Secretary of 

HHS send a letter to the petitioner and the impacted Congressional delegation and the 

Committees of Jurisdiction that NIOSH is missing its statutory deadline, the reason for 

missing the deadline, and the expected date of compliance. Further, to the extent the 

reason is driven by NIOSH’s contractor failing to comply with deadlines or not meeting 

required deliverables, then the contractor’s costs associated with non performance should 

be disallowed in their entirety. 

3. The newly minted definition of a “petition” allows NIOSH to evade Congressional 

direction to process the SEC petitions within 180 days. The IFR establishes a 

definition for the term SEC “petition” in § 83.5 which was not previously defined in the 

SEC rule at 42 CFR Part 83. The IFR Preamble states that “only submissions by qualified 

petitioners that meet the informational and procedural requirements of a petition under 

the rule will be considered to be ‘petitions’ and hence will be covered by the 180-day 

deadline.” Receipt of a SEC petition will be treated as a mere “submission,” and until it is 

“qualified” as meeting the informational and procedural requirements under 42 CFR Part 

83, it will not be deemed a “petition” subject to the 180-day time limits. 

This part of the IFR is completely at odds with the Conference Report which states that 

“During the 180-day period when NIOSH is preparing the petition for review by the 

Advisory Board, NIOSH should identify all deficiencies in the petition within the first 30 

days.”2

 This language directs NIOSH to resolve both petition qualification and evaluation 

within the 180-day time frame, and does not authorize NIOSH to qualify petitions outside 

of the 180-day time period. HHS’s IFR conveniently ignored the Conference Report 

language, and never reconciled the conflict between the IFR and the plain language of the 

Conference Report. 

The HHS definition of “petition” is inconsistent with the 180-day time limits set forth in 

the Conference Report (H. Rep. 108-767) for both the qualification and evaluation of the 

SEC Petition. NIOSH needs to amend the rule to require the 180- day clock to commence 

upon receipt of the SEC petition in the mail and avoid the linguistic redefinition of an 

SEC petition as a mere “submission” when it is received in the mail. The definition of 

“petition” should be deleted or defined as the document received by NIOSH that is 

 2

The IFR makes no reference to qualifying petitions outside the 180 day deadline in 

Conference Report language. 
4

initially submitted by the petitioner. 

Further we note that the IFR sets no time limits on how long it will take to “qualify” a 

petition. The Preamble says it can take “months,” but qualifying a petition is, in general, 

a simple matter of helping petitioners file a technically adequate petition. Some 

qualifying SEC petitions have justifications as short as 1 sentence. Creating an extralegal 

concept of “submission” is nothing more than a transparent effort to weasel additional 

time, and evades the 180-day time limit on an SEC review set forth in Congressional 

Report Language. It is remarkable that 5+ years after enactment of EEOICPA, when 

more than adequate time has elapsed for NIOSH to secure records, that NIOSH is trying 

to get out of deadlines to process SEC petitions in a timely manner. 

In sum, the IFR is in violation of the Conference Report. The term petition should be 

deleted, or modified so as to ensure that the entire SEC review is encompassed within 

180 days. 

4. The IFR unfairly reduces the time for a petitioner to file an appeal regarding the 

“qualification” of an SEC petition to 7 days from the 30 days now contained in 42 

CFR Part 83.11(c). Seven days is far too short of a time period to file an appeal. We 

strongly urge HHS to establish a 30-day time period for petitioners to file an appeal from 

the receipt of a letter disqualifying a petition, and extend all related deadlines should an 

appeal be granted. In the Board Conference call on March 15, 2006, OCAS Director 

Larry Elliott suggested that 7days was not a hardship for petitioners, because all that is 

required is a letter notifying NIOSH that a petitioner desires an appeal. That is not what 

the IFR states. Section 83.11(c) requires that petitioners must “specify why the proposed 

findings should be reversed based on the petition requirements and on the information 

that the petitioners had already submitted.” This requires a full exposition of issues, not a 

mere notification. Mr. Elliott did not retract his misstatement when his interpretation was 

questioned by the ABRWH. Further, the IFR should be clarified to make clear that a 

petitioner may refile a new petition, without prejudice, if new information materializes at 

a later date. 

5. The IFR should define the term “recommendation.” The term “recommendation” 

should be defined as “yes” or “no” on all classes and subclasses covered in a SEC 

petition. The OCAS Director, Larry Elliott, implied on a January 9, 2006-ABRWH 

conference call that a “recommendation” is not necessarily an up-or-down 

recommendation on a petition, but may include a notification that additional time is 

needed to process a part of the SEC petition. He suggested that the term 

“recommendation” is open to legal interpretation, and indicated that this legal 

interpretation was being applied to the pending Oak Ridge Y-12 SEC petition where 

NIOSH established two subclasses within the Y-12 petition. The transcript reflects a 

NIOSH view that staff may exceed the 180-day time limit for making a recommendation 

on a subclass covering the 1948-1957 time period, if it had previously made a 

“recommendation” to approve an earlier time period covering 1942-1947. This SEC 
5

petition for Y-12 plumbers and pipefitters was filed on 2/15/05 and qualified on 4/29/05. 

 The transcript states (pp. 65-67): 

MR. GRIFFON: Paul, before we move on to that, can I just ask Lew or Larry a 

question about the Y-12 petition? 

DR. ZIEMER: Sure. 

MR. GRIFFON: Is there a calendar issue here? When did the clock start ticking, 

and when is the deadline for this evaluation report? Are we – 

MR. ELLIOTT: Well, the clock started ticking when the petition became 

qualified, and we met the 180 day deadline and provided an evaluation report to 

the Board that spoke to the early years of Y-12. And we are still pursuing the 

remainder years for that one petition. 

MR. GRIFFON: The clock for the rest of the remaining years? I don’t 

understand it, but it’s not an issue any more or... 

MR. ELLIOTT: Well, I don’t believe we see it as an issue, that we met the 180-

day mark by providing a recommendation to the Board, an evaluation report on 

the early years, and we have provided a recommendation essentially to the Board 

that we’re continuing our evaluation on the remainder of that petition pending the 

resolution of the site profile issues. 

DR. ZIEMER: We’ve also, those initial deadlines have been met. Now action is 

with the Board and there’s, the clock doesn’t really run for now. Is that correct? 

MR. ELLIOTT: I believe that’s the way we would see it. Mark, does that 

answer your question? 

MR. GRIFFON: Well, it’s an answer, yeah. I just, I thought that the entire, that 

an SEC petition had to have an evaluation report for all members of a class by that 

given deadline. I know this is a little different because it’s been sort of merged, it 

merges three different petitions, but I’m a little unclear, but -- 

MR. ELLIOTT: I think it’s a matter of how one interprets the amendment 

language,...

Mr Elliot’s legal interpretation evades the plain language of the law. It also evades the 

legislative purposes which are to promote prompt processing and provide a complete

recommendation after 180 days. The law states: the Director of the National Institute for 

Occupational Safety and Health shall submit to the Advisory Board on Radiation and 

Worker Health a recommendation on that petition, including all supporting 
6

documentation (emphasis added). 

It is more than a stretch to construe the term “recommendation” to authorize additional 

time, and there is nothing in the law to support that notion. If a “recommendation” can 

include a NIOSH statement that more than 180 days will be taken to process the petition, 

then time limits set forth by Congress are effectively nullified by bureaucratic fiat. 

“Recommendations” are just that—a recommendation to approve or deny a petition with 

supporting documentation. The fact that NIOSH chooses to administratively subdivide 

the petition into different time periods does not grant NIOSH permission to evade the 180 

day deadline. Indifference to Congressional intent is an invitation for more prescriptive 

legislation. Please define the term “recommendation.” 

6. NIOSH should clarify that SEC Evaluation Reports will contain a 

“recommendation.” NIOSH has suggested it may submit “SEC Evaluation Reports” 

without “recommendations” to satisfy the 180-day deadline. NIOSH has separately 

stated that SEC Evaluation Reports will include a “recommendation.” Given these 

contradictory statements, the rule should clarify that SEC Evaluation Reports provided to 

the ABRWH must include a “recommendation.” 

7. NIOSH should set 21 day time limit for transmitting ABRWH Recommendations to 

the Secretary of HHS. The time to transmit an ABRWH recommendation to the 

Secretary has been a source of delay in one very prominent SEC case (IAAP). In 

response, the ABRWH has requested that NIOSH transmit the recommendation and 

administrative record to the Secretary within 21 days. Experience has demonstrated this 

is adequate time to secure transcripts of the ABRWH deliberations, formalize the 

ABRWH’s letter to the Secretary and transmit. This time period should not be left open 

ended if the goal of “prompt” processing is to be honored. Thus, we urge that the rule 

include 21 days for the Advisory Board recommendation to be transmitted to the HHS 

Secretary. 

8. Rule should clarify legal significance of the HHS Review Panel. §83.18 of the IFR 

provides for an administrative review of a “final” Secretarial decision to deny a SEC 

petition by a 3-person HHS Review Panel. However, the HHS Review Panel findings and 

recommendations in §83.18 are not binding on the Secretary. Their findings are purely 

advisory in the IFR. Please clarify whether a petitioner’s exhaustion of remedies occurs 

upon issuance of a final Secretarial determination, or whether appeal to this Review Panel 

is necessary prior to a petitioner seeking judicial review of a Secretarial determination. 

Please explain how the HHS Review Panel is considered an appeals body, if the 

Secretary can freely ignore the HHS Review Panel findings? 

9. The identity and contact information of SEC petitioners under Section 83.13 should 

be disclosed in the interest of transparency. If necessary, 42 CFR Part 83 should be 

amended accordingly. The HHS rule presently states at 42 CFR Part 83: 

 
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"In considering the petition, both NIOSH and the members of the Board will take 

all steps necessary to prevent the disclosure of information of a personal nature, 

concerning the petitioners or others, where disclosure would constitute a clearly 

unwarranted invasion of personal privacy." 

NIOSH has interpreted “information of a personal nature” to include the names and 

contact information of the SEC petitioners in Y-12, ORINS, Chapman Valve, and several 

others locations. Is it appropriate for Section 83.13 SEC petitioners to be 

afforded complete anonymity when they are the public's representative in the SEC 

proceedings under Section 83.13 which will affect hundreds if not thousands of potential 

claimants? Is it an “unwarranted invasion of personal privacy” for NIOSH to provide 

limited information—such as petitioners’ names and contact information--to members of 

the affected SEC class? 

A balancing test needs to be undertaken which weighs anonymity against the fact that 

SEC petitioners are (self-selected) representatives of the public, and there is a necessity 

for interested SEC class members or others to communicate relevant information to the 

petitioners representing a class. It is not an “unwarranted” invasion of personal privacy 

to disclose the names and contact information (while excluding protected information, 

such as Social Security Numbers or medical information) given the public role that is 

assumed when individuals purport to speak (or not) on behalf of an entire SEC class. 

NIOSH OCAS Director Larry Elliott revealed on the January 9, 2006 ABRWH 

conference call, for example, that he has spoken with the two Y-12 petitioners, and he 

claims they have acceded to his various requests and legal interpretations of the 180-day 

rule. These two Y-12 SEC petitioners are representing a large class of individuals—

perhaps in excess of 1000--whose interests are directly affected by actions they take or 

fail to take. 

It is noteworthy that the Y-12 petitioners have apparently not participated in the Working 

Group sessions or Board calls. They did not identify themselves at the ABRWH meeting 

in Oak Ridge, TN. They are petitioners in absentia, and equity suggests that others 

impacted by this SEC Petition should be permitted to make contact with the Petitioners 

and determine their reasons for non participation, or make appropriate arrangements for 

additional or substitute participation on behalf of the class in Working Groups, Board 

meetings and other communications. History has demonstrated the imperative of 

informed participation by SEC petitioners in the process. Needless secrecy forecloses 

this possibility. I hope this is not NIOSH’s intent. 

 

The rule should be modified to advise the Section 83.13 petitioners that their identity and 

contact information will be disclosed. Should such limited disclosure be deemed 

unpalatable, nothing requires such individuals to become SEC petitioners under 83.13. 

Individuals do not have an expectation of anonymity when they file a comment on a site 

profile or in this rulemaking, nor should they when it involves matters of applicability 

affecting an entire class under Section 83.13. 
8

 

 Thank you for consideration of these comments. Please contact Richard Miller at 202-

408-0034, x 127, or e-mail at rickudana@aol.com if you have any questions. 

 Sincerely, 

 Richard Miller 

 Senior Policy Analyst